PD-1 (Programmed Death-1) Versus PD-L1 (Programmed Death-ligand 1) Immune Check Point Inhibitors Combined With Chemotherapy, With or Without Bevacizumab, In Patients With Metastatic, Persistent Or Recurrent Cervical Cancer

NCT07472153 | Recruiting Phase 2

• 1 other identifier: 20260013
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized trial evaluating the results of using of PD-1 and PD-L1 immune checkpoint inhibitors combined with chemotherapy, with or without bevacizumab, in patients with metastatic, persistent, and recurrent cervical cancer.

Conditions

Metastatic Cervical Cancer; Persistent Cervical Cancer; Recurrent Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Time from randomization to the death of any cause

  From enrollment through study completion, an average of 2 year

• Median overall survival

  The timepoint at which 50% of patients are still alive following treatment initiation

  From date of treatment initiation until the date of death from any cause, assessed up to 36 months

Secondary Outcomes (4)

• Objective response rate

  From randomization until progression or study completion, average of 60 months

• Duration of response

  From date of first documented response until progression or death, assessed up to 60 months

• Disease-free survival

  From enrollment through study completion, an average of 2 year

• Median Disease-free survival

  From date of treatment initiation until the date of death from any cause, assessed up to 36 months

Other Outcomes (2)

• The frequency of immune-related adverse events

  Through From date of first immunotherapy dose through 60 months, or date of last patient contact

• The frequency of discontinuation of immunotherapy

  From date of first immunotherapy dose through 60 months, or date of last patient contact

Study Arms (3)

PD-1

EXPERIMENTAL

Drug: PD-1 antibody

PD-L1

EXPERIMENTAL

Drug: PD-L1 antibody

Standard

ACTIVE COMPARATOR

Drug: Chemotherapy and bevacizumab (CT-BEV)

Interventions

PD-1 antibody DRUG

Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 + PD-1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of treatment according to the regimen of PD-1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days.

PD-1

PD-L1 antibody DRUG

Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 + PD-L1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of treatment according to the regimen of PD-L1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days.

PD-L1

Chemotherapy and bevacizumab (CT-BEV) DRUG

Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of bevacizumab 7-10 mg/kg every 21 days.

Standard

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18-≤75 years.
• Histologically confirmed diagnosis.
• One of the forms of the cervical cancer:
• Metastatic cervical cancer (stage IVB according to FIGO (International Federation of Gynaecology and Obstetrics) 2018);
• Persistent cervical cancer (primary incurability after radical treatment for stages IIB-IVA cervical cancer according to FIGO 2018);
• Reccurent cervical cancer (first recurrence after completed radical treatment for IA-IVB cervical cancer according to FIGO 2018).
• Availability of material for determining PD-L-1 expression for immunotherapy candidates.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• No contraindications to chemotherapy, immunotherapy, or bevacizumab.
• Signed informed consent to participate in the study.

You may not qualify if:

• Presence of another active malignant invasive neoplasm.
• Pregnancy or lactation period.

Sponsors & Collaborators

• N.N. Alexandrov National Cancer Centre: lead

Study Sites (1)

N.N. Alexandrov National Caner Centre

Minsk, Lesnoy, 223040, Belarus

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

spartalizumab; Drug Therapy; Bevacizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yana Kamko

CONTACT

80259111218; kazache.yana@gmail.com

Sergey Mavrichev

CONTACT

smavrichev71@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 16, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2033
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

BE (1)